Difference between revisions of "Necitumumab (Portrazza)"

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(FDA approval)
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=Mechanism of action=
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==General information==
Monoclonal antibody directed against EGFR
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Class/mechanism: Recombinant human IgG1 EGFR monoclonal antibody. Necitumumab binds to the human epidermal growth factor receptor (EGFR) prevents it from binding to its ligands.  This interferes with EGFR's effects on growth of malignant cells, angiogenesis, and inhibition of apoptosis.  In vitro, necitumumab has been observed to cause antibody-dependent cellular cytotoxicity (ADCC) in cells which express EGFR, induce the internalization of EGFR, and lead to its degradation.<ref name=insert>[http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125547s000lbl.pdf Necitumumab (Portrazza) package insert]</ref><ref>[[Media:Necitumumab.pdf|Necitumumab (Portrazza) package insert (locally hosted backup)]]</ref><ref>[http://portrazza.com/ Portrazza manufacturer's website]</ref>
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<br>Route: IV
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<br>Extravasation: no information
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For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer.  Instead, for the most current information, please refer to your preferred pharmacopeias such as [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref>
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==Diseases for which it is used==
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*[[Non-small cell lung cancer]]
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==Patient drug information==
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*Brief patient counseling information can be found in the [http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125547s000lbl.pdf Necitumumab (Portrazza) package insert]<ref name="insert"></ref>
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==History of changes in FDA indication==
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*11/24/2015: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm474278.htm FDA approved] to be used "in combination with [[Gemcitabine (Gemzar)|gemcitabine]] and [[Cisplatin (Platinol)|cisplatin]], for first-line treatment of patients with metastatic squamous [[non-small cell lung cancer]].<ref name="insert"></ref>
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==Also known as==
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IMC-11F8
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==References==
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<references/>
  
 
[[Category:Drug index]]
 
[[Category:Drug index]]
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[[Category:Anti-EGFR antibodies]]
 
[[Category:Anti-EGFR antibodies]]
  
[[Category:Investigational]]
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[[Category:Non-small cell lung cancer medications]]
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[[Category:Drugs FDA approved in 2015]]

Revision as of 04:43, 25 November 2015

General information

Class/mechanism: Recombinant human IgG1 EGFR monoclonal antibody. Necitumumab binds to the human epidermal growth factor receptor (EGFR) prevents it from binding to its ligands. This interferes with EGFR's effects on growth of malignant cells, angiogenesis, and inhibition of apoptosis. In vitro, necitumumab has been observed to cause antibody-dependent cellular cytotoxicity (ADCC) in cells which express EGFR, induce the internalization of EGFR, and lead to its degradation.[1][2][3]
Route: IV
Extravasation: no information

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]

Diseases for which it is used

Patient drug information

History of changes in FDA indication

Also known as

IMC-11F8

References